No experimentation without consent is one of the few ethical principles which is universally accepted by bioethicists. But some exceptions are needed for studies of non-competent patients and emergency medicine. One of these has prompted a fierce debate: a US trial of an experimental blood substitute for accident victims. The product, PolyHeme, is made by an Illinois company, Northfield Laboratories, which has enlisted 32 hospitals throughout the country.

In areas covered by the trial, the company has consulted with the local community to explain what happens. The only way to opt out is to wear a blue wristband. Critics say that community awareness is low, there is little public awareness of the risks and consultation has been inadequate. The trials tend to take places where there are lots of trauma — mostly poor towns with ethnic minorities. Another issue is supposed lack of information about the results of the trial. It is also under fire for not disclosing the results of a study which apparently showed that some patients suffered heart attacks.

The PolyHeme study is being observed carefully because other “no consent” trials are under way. In the coming months, a $50 million National Institutes of Health research project will test experimental techniques on trauma and heart-attack patients who cannot give consent.

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Michael Cook

Michael Cook edits BioEdge, a bioethics newsletter, and MercatorNet, an on-line magazine whose focus is human dignity. He writes from Sydney, Australia.

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